Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement

NCT05391607 | Completed Phase 4

• 1 other identifier: VASCALB
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion. The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure. Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.

Conditions

Blood Loss, Surgical; Fluid Retention

Keywords

hyperoncotic; isooncotic; albumin 20%; albumin 5%; ringer lactate; blood loss; hemorrhage; fluid replacement; intravascular effect; volume expansion; cystectomy; pro-ANP; pro-BNP; glycocalyx proteins; microcirculation damages; endothelial shedding; CD138/syndecan 1; heparan sulfate; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Plasma volume expansion

  Difference in plasma volume expansion of albumin 20%, albumin 5% and Ringer lactate calculated by volume kinetics

  5 hours

Secondary Outcomes (5)

• Biological markers (pro-ANP and pro-BNP)

  24 hours

• Cardiac output (CO)

  5 hours

• Endothelial damage

  24 hours

• Stroke volume (SV)

  5 hours

• Pleth variability index (PVI)

  5 hours

Study Arms (3)

Albumin 20%

EXPERIMENTAL

3mL/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Drug: Hyperoncotic Albumin 20%

Albumin 5%

EXPERIMENTAL

12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Drug: Isooncotic Albumin 5%

Ringer-lactate

ACTIVE COMPARATOR

Ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Drug: Ringer's Lactate Crystalloid Solutions (control group)

Interventions

Hyperoncotic Albumin 20% DRUG

Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Also known as: Albumin 20%

Albumin 20%

Isooncotic Albumin 5% DRUG

Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Also known as: Albumin 5%

Albumin 5%

Ringer's Lactate Crystalloid Solutions (control group) DRUG

Intravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Also known as: Ringer Lactate

Ringer-lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non emergent radical cystectomy with urinary diversion
• Adult: older than 18 years
• Written informed consent

You may not qualify if:

• Contraindications to the class of drugs under study (i.e: known hypersensitivity/ allergy to class of drugs or to the investigational product).
• Renal insufficiency: GFR: \<60ml/min/1.73m2 (KDIGO Clinical Practice Guideline for Acute Kidney Injury, stage 3 and over).
• History of heart failure.
• Use of diuretic treatment.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• Jardot F, Hahn RG, Huber M, Wuethrich PY. Detection of hypovolemia by non-invasive hemodynamic monitoring during major surgery using Ringer s solution, 5% albumin, or 20% albumin as infusion fluid: a post-hoc analysis of a randomized clinical trial. Crit Care. 2025 Mar 23;29(1):132. doi: 10.1186/s13054-025-05357-z.

  PMID: 40122881 DERIVED

• Jardot F, Hahn RG, Engel D, Beilstein CM, Wuethrich PY. Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial. Crit Care. 2024 Feb 5;28(1):39. doi: 10.1186/s13054-024-04821-6.

  PMID: 38317178 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Interventions

galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20; zidovudine 5'-monophosphate-mannose-albumin conjugate; Control Groups; Ringer's Lactate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Patrick Y Wuethrich, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: May 25, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 10, 2023
• Last Updated: April 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)